NCT00045526

Brief Summary

This phase II trial is studying erlotinib hydrochloride to see how well it works in treating patients with advanced esophageal cancer or stomach cancer. Erlotinib hydrochloride may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2002

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

4.7 years

First QC Date

September 6, 2002

Last Update Submit

June 3, 2013

Conditions

Adenocarcinoma of the EsophagusAdenocarcinoma of the Gastroesophageal JunctionRecurrent Esophageal CancerSquamous Cell Carcinoma of the EsophagusStage III Esophageal CancerStage IV Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • Major response rate (complete and partial response)

    Up to 5 years

Secondary Outcomes (4)

  • Toxicities, graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC)

    Up to 5 years

  • Degree of dysphagia relief

    Up to 5 years

  • Time to progression

    Up to 5 years

  • Overall survival

    Up to 5 years

Study Arms (1)

Treatment (erlotinib hydrochloride)

EXPERIMENTAL

Patients receive erlotinib hydrochloride PO QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: erlotinib hydrochlorideOther: laboratory biomarker analysis

Interventions

erlotinib hydrochlorideDRUG

Given PO

Also known as: CP-358,774, erlotinib, OSI-774
Treatment (erlotinib hydrochloride)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (erlotinib hydrochloride)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed adenocarcinoma, squamous cell or small cell carcinoma, or carcinoma not otherwise specified of the esophagus or gastroesophageal junction
  • Metastatic or surgically unresectable disease
  • Measurable disease outside of primary tumor
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral computed tomography (CT) scan
  • No bone metastases, abnormal radionuclide bone scans, or pleural effusions as only site of measurable disease
  • No known brain metastases or carcinomatous meningitis
  • Must consent to having tumor tissue tested for epidermal growth factor receptor status
  • Performance status-Karnofsky 70-100%
  • Life expectancy of greater than 3 months
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) no greater than 2 times ULN
  • Creatinine no greater than 1.5 mg/dL
  • Calcium no greater than 12 mg/dL
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Adenocarcinoma Of EsophagusEsophageal NeoplasmsEsophageal Squamous Cell Carcinoma

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • David Ilson

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2002

First Posted

January 27, 2003

Study Start

June 1, 2002

Primary Completion

February 1, 2007

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

US(1)